Randomized Cross over Clinical Study on Efficacy of Yashtimadhu Taila Shirodhara and Yoga Nidra in Chronic Insomnia
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Improvement in sleep quality, sleep duration, awakenings during night by using Athens Insomnia Scale before and after treatment.
研究概览
简要总结
It is a Randomized Cross over Clinical Study on Efficacy of Yashtimadhu Taila Shirodhara and Yoga Nidra in Chronic Insomnia.
Total 40 patients will be enrolled.
Yashtimadhu Taila Shirodhara and Yoga Nidra therapies will be given to 20 patients each for 7 days.
· After washout period of 10 days, crossover will be done and Yashtimadhu Taila Shirodhara and Yoga Nidra therapies will be given to 20 patients each for 7 days.
· Follow up on 8th, 18th and 25th day of the patient will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with Chronic Insomnia as per Insomnia DSM-5-TR- Criteria.
- •2.Patients with symptoms of Angamarda, Jrumbha, Shirogaurav, Glani, Klama.
排除标准
- •1.Known cases of Bipolar disorder or Schizophrenia.
- •2.Patient with medical conditions known to significantly impact sleep quality or require specialized treatment e.g. sleep apnea, restless leg syndrome, chronic pain disorders.
- •3.Patients using prescribed sleep medications or over the counter sleep aids.
- •4.Patient with history of substance abuse or dependence.
- •5.Shift workers.
- •6.Pregnant and lactating women.
结局指标
主要结局
1.Improvement in sleep quality, sleep duration, awakenings during night by using Athens Insomnia Scale before and after treatment.
时间窗: 24 days
2.Reduction in symptoms of Angamarda or Shirogaurav or Glani or Klama or Jrumbha.
时间窗: 24 days
次要结局
- Evaluate & compare the reduction in symptoms of Angamarda or Shirogaurav or Glani or Klama or Jrumbha.
研究者
Dr Samruddhi Vaidkar
Dr. D. Y. Patil College of Ayurved and Research Centre